The primary objective of the trial is to demonstrate that lorcaserin has superior efficacy compared to placebo as measured by percent change in frequency of convulsive seizures per 28 days.
Orrin Devinsky, MD
After consulting with the FDA, Eisai has announced that it has initiated the phase 3 MOMENTUM1 (also known as Study 304; NCT number pending) clinical study, which will evaluate lorcaserin in patients with Dravet syndrome (DS). In addition, Eisai will also continue the lorcaserin expanded access program (EAP; Study 405; NCT04457687), also known as the MOMENTUM2 study.
MOMENTUM1 is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study that has a target enrollment of 58 subjects with DS who will be evaluated at approximately 20 sites in the United States. Lorcaserin, a selective serotonin 5-HT2c receptor agonist, will be used as an adjunctive treatment in both the phase 3 trial, as well as an open-label extension.
Orrin Devinksy, MD, professor of neurology, NYU Grossman School of Medicine, and MOMENTUM1 lead investigator, said in a statement, “there is an urgent need to find new treatment options for Dravet syndrome, and we hope the new MOMENTUM1 study will yield positive clinical outcomes for participants and potential new therapy.”
Investigators will be assessing whether lorcaserin has superior efficacy compared to placebo in patients as measured by percent change in frequency of convulsive seizures per 28 days. Superior efficacy between the 2 groups will also be observed for their 50% responder rate, which measures the percent of subjects with at least 50% reduction in frequency of convulsive seizures per 28 days.
READ MORE: FDA Issues CRL for Diazepam Buccal Film for Seizure Cluster Treatment
Additional secondary end points of the study include evaluating whether lorcaserin has superior efficacy compared to placebo by the proportion of subjects who are free from convulsive seizures, safety and tolerability, the pharmacokinetics (PK) of lorcaserin and the relationship between lorcaserin plasma concentrations, efficacy, and safety.
"This important research exemplifies our human health care mission as it was prompted by the limited number of approved treatments for this condition along with the voices of patients, caregivers, and health care professionals who reported their clinical experience with lorcaserin in this severe form of epilepsy,” Lynn Kramer, MD, chief clinical officer, Neurology Business Group, Eisai, said in a statement.
BELVIQ, an FDA-approved weight-loss medication in which lorcaserin is the primary ingredient, was withdrawn from the market in February 2020 after data from the CAMELLIA-TIMI 61 trial showed a numerical imbalance in the number of patients with malignancies. Following the withdrawal, Eisai noted that they received multiple requests from patients, caregivers, and health care professionals for continued access to patients who were prescribed BELVIQ to help treat DS, as well as other refractory epilepsies.
The added requests prompted a consultation with the FDA, who then agreed with Eisai about the importance of patient access to lorcaserin for Dravet syndrome, to the extent of each individuals’ health care provider’s belief in the continued access as medically appropriate.
As a result, MOMENTUM2, a centralized EAP that includes patients with DS and other refractory epilepsies who were prescribed lorcaserin by their treating physician prior to the market withdrawal, will continue. Within that study, there will be a PK sub-study and a retrospective chart review. Investigators will also gather information on seizure frequency, PK data, and safety of lorcaserin exposure.
Dosage will be flexible throughout the study and the treating physician will make final judgment calls on dosing and visit intervals.
“We commend the FDA for recognizing the tremendous unmet medical needs of patients living with Dravet syndrome and for providing Eisai with the opportunity to conduct the phase 3 MOMENTUM1 study,” Kramer concluded in a statement. Eisai did not indicate what the expected conclusion date of either trial , nor when the first patients are expected to be dosed.